FDA issues final guidance on mobile medical apps

That’s right folks, FDA has issued it’s final guidance for developers of mobile medical applications.

The FDA is focusing its oversight on mobile medical apps that:

  • are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or
  • transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

To read the document or simply to find out more, surf on to the official press release here.

About Adam Chee

Health Informatician
This entry was posted in !Updates & Ramblings. Bookmark the permalink.

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